[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Rules and Regulations]
[Pages 28820-28821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11026]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558


New Animal Drugs for Use in Animal Feeds; Oxytetracycline

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of two supplemental new animal 
drug applications (NADAs) filed by Phibro Animal Health, Inc. The 
supplemental NADAs provide for a 0-day preslaughter withdrawal time for 
use of oxytetracycline in cattle feed.

DATES:  This rule is effective May 19, 2004.

FOR FURTHER INFORMATION CONTACT: Joan C. Gotthardt, Center for 
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-7571, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: Phibro Animal Health, 710 Rt. 46 East, suite 
401, Fairfield, NJ 07004, filed supplements to NADA 8-804 for TM-50, 
TM-50D, TM-100, and TM-100D (oxytetracycline) Type A medicated articles 
and NADA 95-143 for TERRAMYCIN 50, TERRAMYCIN 100, and TERRAMYCIN 200 
(oxytetracycline) Type A medicated articles used for making medicated 
feeds for the treatment of various bacterial diseases of livestock. The 
supplemental NADAs provide for a 0-day withdrawal time prior to 
slaughter when Type C medicated feeds containing oxytetracycline are 
fed continuously to calves, beef cattle, and nonlactating dairy cattle 
at a dosage of 10 milligrams per pound of body weight for up to 14 
days. The supplemental NADAs are approved as of March 12, 2004, and the 
regulations are amended in 21 CFR 558.450 to reflect the approval. The 
basis of approval is discussed in the freedom of information summaries.
    In accordance with the freedom of information provisions of 21 CFR 
part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and 
effectiveness data and information submitted to support approval of 
these applications may be seen in the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33(a)(1) that these 
actions are of a type that do not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C. 
804(3)(A) because it is a rule of ``particular applicability.'' 
Therefore, it is not subject to the

[[Page 28821]]

congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

    Animal drugs, Animal feeds.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is 
amended as follows:

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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1. The authority citation for 21 CFR part 558 continues to read as 
follows:

    Authority: 21 U.S.C. 360b, 371.


Sec.  558.450  [Amended]

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2. Section 558.450 Oxytetracycline is amended in the table in paragraph 
(d)(1)(ix) in entries 1 and 2 in the ``Limitations'' column by removing 
``withdraw 5 d before slaughter'' and by adding in its place ``for No. 
053389, withdraw 5 d before slaughter; for No. 066104, 0-day 
withdrawal''.

    Dated: April 14, 2004.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary 
Medicine.
[FR Doc. 04-11026 Filed 5-18-04; 8:45 am]
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